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news.A phase II trial of biopharmaceutical company Acologix investigational compound, AC-100, has met its primary endpoint of stimulating the formation of dentin - the hard tissue of teeth that protects the tooth pulp and supports the outer enamel.
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AC-100, a novel synthetic peptide derived from an endogenous human protein produced by bone and dental cells, also demonstrated a favorable safety profile.
Each year, more than 200 million dental restoration procedures are performed in the US. Drilling during these procedures irritates the dental pulp and reduces the dentin layer that protects the pulp, causing pain and sensitivity, and sometimes leading to complications, including tooth loss.
“This phase II clinical study demonstrates that a novel biological approach to dentistry, by modulating normal cell functions to stimulate the innate biological defenses of the tooth, can be introduced as a supplement to routine dental care,” said Dr Cornelis Pameijer, study author and professor emeritus of prosthodontics at the University of Connecticut, School of Dental Medicine.
In addition to dental applications, Acologix is also studying AC-100 for periodontal, oral bone, dental implant and orthopedic applications. Phase II study results of AC-100 used in periodontal surgery are expected later this year.